Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of Effectiveness and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease; A Multicenter, Prospective, Observational Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825886
• Other study ID #: CNUH-2017-319
• Status: Completed
• Start date: December 28, 2017
• Est. completion date: March 18, 2022

Study information

• Verified date: February 2024
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Description:

Study objectives:

From this observational prospective study, the efficacy and safety of Zotarolimus-Eluting Stent in patients with coronary artery disease longer than 25mm is planned to be investigated.

Background:

Long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. Zotarolimus-Eluting Stents are a new type of stent that combines the advantages of an Endeavour Resolute stent (drug eluting stent) and Integrity stent (bare metal stent). In other words, BioLinx polymer is used which is an advantage of Endeavour Resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of Integrity stent. To date, there are only few studies to evaluate the efficacy and safety of Zotarolimus-Eluting Stent in the treatment of coronary artery disease. Therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age = 19 years old

• Evidence of myocardial ischemia and coronary artery diameter stenosis= 50% and lesion length = 25mm

• At least 2.5 mm diameter coronary vessel by visual estimation

• Patients treated with Zotarolimus-eluting stent

Exclusion Criteria:

• Previous coronary stent implantation

• Patients perticipated in other clinical trials of drugs or device

• Target vessel saphenous vein graft

• In-stent re-stenosis lesion

• Contraindicated to anti-platelet agents or hypersensitivity

• Past history of malignancy within 5 years

• History of anaphylaxis to contrast agent

• Pregnancy and lactation

• Life expectancy < 1-year

• End stage renal disease on dialysis

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Zotarolimus-Eluting Stent
Percutaneous coronary intervention using zotarolimus-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Konkuk University Medical Center	Chungju
Korea, Republic of	Daegu Catholic University Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Eulji Medical Center	Daejeon
Korea, Republic of	Kongyang Univeristy Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Wongkwang University Hospital	Iksan
Korea, Republic of	Jeonbuk National University Hospital	Jeonju
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Kosin University Gospel Hospital	Pusan
Korea, Republic of	Paik Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Saint Carollo Hospital	Suncheon
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel	Index admission to 12 months
Secondary	All-cause death	Cumulative incidence rate of all-cause death at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	Cardiac death	Cumulative incidence rate of cardiac death at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	Myocardial Infarction	Cumulative incidence rate of myocardial infarction at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	All-cause death or Myocardial infarction	Cumulative incidence rate of all-cause death or myocardial infarction at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	Cardiac death or Myocardial infarction	umulative incidence rate of cardiac death or myocardial infarction at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	Target vessel revascularization	Cumulative incidence rate of target vessel revascularization at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	Target lesion revascularization	Cumulative incidence rate of target lesion revascularization at each visit	Index admission, 1 month, 6 months, 12 months
Secondary	Stent thrombosis	Cumulative incidence rate of stent thrombosis at each visit	Index admission, 1 month, 6 months, 12 months